Publications by authors named "Jose L Navia"

102 Publications

Aortic allograft for endocarditis of the intervalvular fibrosa.

Ann Thorac Surg 2021 Feb 20. Epub 2021 Feb 20.

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, 9500 Euclid Ave, Desk J4-1, Cleveland, OH 44195.

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http://dx.doi.org/10.1016/j.athoracsur.2020.11.085DOI Listing
February 2021

Management of peri-device leak following left atrial appendage closure: A systematic review.

Catheter Cardiovasc Interv 2021 Aug 1;98(2):382-390. Epub 2021 Feb 1.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic Florida, Weston, Florida.

Objective: This study aimed to examine the cumulative experience of peri-device leak (PDL) closure following left atrial appendage (LAA) closure.

Background: The management of PDL following LAA closure remains controversial. While PDL closure has been proposed, procedural features and clinical outcomes have not been well established.

Methods: A systematic review of all published cases of PDL closure with available anatomical, procedural, and clinical outcomes was performed.

Results: We identified 18 indexed publications and 110 cases between April 2013 and March 2020. 71 patients (mean age 72 ± 8 yrs), met study criteria and were included. PDL closure was most common in males, bilobar LAA morphology, and after Watchman procedures. The mean PDL size was 7.6 ± 5.8 mm (range 2-26 mm). Leaks were classified according to size: small (<5 mm; 45%), moderate (≥5-9 mm; 25%), and large (≥10 mm; 30%). Endovascular coils and endovascular plugs were used to close both small and moderate sized leaks, and second LAA closure devices were exclusively used for large PDLs. Successful PDL closure occurred in 90%, and was similar between PDL sizes and types of occluder used. Procedural complication rates were uncommon (2.8%). No strokes were reported following PDL closure at 6 months.

Conclusions: In patients with PDL for whom discontinuation of OAC may be considered unsafe, percutaneous closure using a tailored approach with either endovascular coils, plugs, or second occluder represents a safe, and feasible alternative associated with favorable clinical outcomes.
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http://dx.doi.org/10.1002/ccd.29495DOI Listing
August 2021

Right versus left heart reverse remodelling after treating ischaemic mitral and tricuspid regurgitation.

Eur J Cardiothorac Surg 2020 Nov 14. Epub 2020 Nov 14.

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, USA.

Objectives: Repair outcomes of tricuspid regurgitation (TR) associated with ischaemic mitral regurgitation (IMR) are inferior to functional TR in terms of TR recurrence and right ventricular (RV) reverse remodelling. Our objective is to analyse right versus left heart reverse remodelling after surgery for IMR-associated TR.

Methods: From 2001 to 2011, 568 patients with severe IMR underwent mitral valve surgery (repair 87%, replacement 13%), and 131 had concomitant tricuspid valve repair. Median follow-up was 3.0 years; 25% of living patients were followed up for 6.3 years. Longitudinal analysis of 1527 follow-up echocardiograms was performed to assess ventricular reverse remodelling and function.

Results: Unlike the left heart, the right heart failed to reverse remodel (failed to recover ventricular function or halt dilatation). During follow-up after surgery, the right ventricle continued to dilate while the left ventricle regressed in size. RV ejection fraction decreased (46% at 1 month and 44% at 5 years), while left ventricular ejection fraction increased (33% and 37%, respectively). RV strain showed early (-11% at 1 month) and late (-12% at 5 years) dysfunction. Patients who underwent tricuspid valve repair had worse RV function. Mitral regurgitation remained stable after surgical intervention, and TR gradually recurred (37% moderate, 20% severe at 7 years).

Conclusions: Surgical treatment of IMR and TR along with revascularization failed to induce reverse remodelling of the right heart. These findings warrant further investigations to identify optimal timing and approach of intervention for IMR-associated TR with respect to RV remodelling.
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http://dx.doi.org/10.1093/ejcts/ezaa326DOI Listing
November 2020

Successful mobile extracorporeal membrane oxygenator for COVID-19 severe respiratory failure.

J Card Surg 2020 Dec 10;35(12):3655-3657. Epub 2020 Oct 10.

Department of Cardiothoracic Surgery, Cleveland Clinic Florida, Weston, Florida, USA.

High volume extracorporeal membrane oxygenation (ECMO) centers have developed mobile ECMO programs in recent years to facilitate the implementation of ECMO support at hospitals with lower capabilities, and transfer these patients for further care. We report a case of mobile ECMO on a patient with coronavirus disease 2019-related acute respiratory distress syndrome, and discuss the potential application in the current severe acute respiratory syndrome coronavirus 2 pandemic.
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http://dx.doi.org/10.1111/jocs.15106DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7675363PMC
December 2020

'Minimalist approach' for transcatheter mitral valve replacement using intracardiac echocardiography and conscious sedation: a case series.

Eur Heart J Case Rep 2020 Jun 24;4(3):1-5. Epub 2020 Apr 24.

Department of Cardiology, Heart & Vascular Institute, Cleveland Clinic Florida, 2590 Cleveland Clinic Blvd, Weston, FL 33331, USA.

Background: Transcatheter aortic valve implantation operators have adapted to a less invasive technique by foregoing the use of general anaesthesia and transoesophageal echocardiography. This is known as a 'minimalist approach'. This approach has yet to be explored in transcatheter mitral valve replacement (TMVR). Two patients with high perioperative risk underwent TMVR using only monitored conscious sedation (CS) and intracardiac echocardiography (ICE).

Case Summary: The patients were symptomatic and required treatment of severe mitral regurgitation and severe mitral stenosis in a mitral valve ring and prosthetic mitral valve, respectively. With the use of an antegrade transseptal approach, the procedure was conducted under CS using ICE only. After placement of the prosthetic mitral valve, the valve was assessed by advancing the ICE catheter through the interatrial septal defect and no significant paravalvular leak occurred. In one case, treatment of right to left shunting was successfully pursued. Valve function was excellent immediately and at 24 h after implantation and resulted in significant haemodynamic improvement.

Conclusion: With more TMVR cases being conducted, the 'minimalist approach' with CS and ICE may be considered in selected cases.
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http://dx.doi.org/10.1093/ehjcr/ytaa058DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7319820PMC
June 2020

Coronary Artery Bypass Graft Patency and Survival in Patients on Dialysis.

J Surg Res 2020 10 7;254:1-6. Epub 2020 May 7.

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: Little is known about graft patency after coronary artery bypass grafting (CABG) performed in patients on dialysis. Our aim was to assess patency of internal thoracic artery (ITA) grafts and saphenous vein grafts (SVGs) in these patients.

Methods: From 1/1997 to 1/2018, 500 patients on dialysis underwent primary CABG with or without concomitant procedures at Cleveland Clinic, 40 of whom had 48 postoperative angiograms for recurrent ischemic symptoms. Complete follow-up was obtained on all but 1 patient lost to follow-up 1 y after CABG. Thirty-six ITA grafts and 65 SVGs were evaluable for stenosis and occlusion.

Results: Two of 40 patients (5%) had emergency CABG; 3 (7.5%) with calcified aortas had a change in operative strategy to avoid ascending aortic manipulation, 2 (5%) had poor conduit quality, and 12 (30%) had severe diffuse atherosclerotic disease with calcification of the coronary targets causing technical difficulties. Thirty-three patients (82%) were bypassed with an in situ ITA and 3 (7.5%) had a free ITA graft. Three of 36 ITA grafts were occluded at 0.78, 1.8, and 9.4 y (too few to model). SVG patency was 52% and 37% at 1 and 2 y, respectively.

Conclusions: Among patients on dialysis who underwent CABG, coronary angiography for ischemic symptoms in a select subset revealed that SVG patency was lower than expected from published reports in the general CABG population and may contribute to the poor prognosis of this cohort. Further work is needed to guide graft selection and improve graft patency in dialysis patients.
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http://dx.doi.org/10.1016/j.jss.2020.03.069DOI Listing
October 2020

First Experience Using a Nonfenestrated Cardioform Septal Occluder for Closure of Giant Mitral Paravalvular Leak.

JACC Case Rep 2020 Mar 18;2(3):468-472. Epub 2020 Mar 18.

Section for Structural Heart Disease, Heart and Vascular Center, Cleveland Clinic Florida, Weston, Florida.

A variety of fenestrated vascular plugs have been used to seal paravalvular leaks with meaningful success; however, incomplete closure and refractory hemolysis remains a common problem. We describe the feasibility and rationale of their first experience using a nonfenestrated Cardioform Septal Occluder (Gore Medical, Flagstaff, Arizona) to treat a giant mitral paravalvular leak. ().
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http://dx.doi.org/10.1016/j.jaccas.2019.12.027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311613PMC
March 2020

Coronary Artery Target Selection and Survival After Bilateral Internal Thoracic Artery Grafting.

J Am Coll Cardiol 2020 01;75(3):258-268

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.

Background: The importance of a coronary artery, based on the myocardial mass it perfuses, is well documented, but little is known about the importance of a vessel that has been bypassed and its effect on survival in the context of bilateral internal thoracic artery (BITA) grafting.

Objectives: This study determined the effect of a dominant left anterior descending (LAD) artery and important non-LAD targets on outcomes after BITA grafting.

Methods: From January 1972 to January 2011, of 6,127 patients who underwent BITA grafting, 2,551 received 1 ITA grafted to the LAD and had an evaluable coronary angiogram. A dominant LAD was defined as one that was wrapped around the left ventricular apex. Non-LAD targets were graded based on their terminal reach toward the apex: important: >75% (n = 1,698); and less important: ≤75% (n = 853). Mean follow-up was 14 ± 8.7 years. Multivariable analysis was performed to identify risk factors for time-related mortality.

Results: A dominant LAD was present more frequently in patients with less important additional targets (51% vs. 35%; p < 0.0001). A total of 179 patients (7.0%) received a second ITA to multiple targets, 77 (43%) of which were to multiple important target vessels. Unadjusted late survival was similar regardless of degree of importance of the second ITA target-77% at 15 years (p = 0.70) for the important and less important targets, respectively. In the multivariable model, grafting the second ITA to multiple important targets was associated with better long-term survival (p = 0.005). In patients with a nondominant LAD, a second ITA grafted to a less important artery was associated with higher risk of operative mortality (2.4% vs. 0.51%; p = 0.007). A saphenous vein graft to an important or less important target did not influence long-term survival.

Conclusions: In BITA grafting, bypassing multiple important targets to maximize myocardium supplied by ITAs improved long-term survival. In patients with a nondominant LAD, selecting an important target for the second ITA lowered operative mortality.
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http://dx.doi.org/10.1016/j.jacc.2019.11.026DOI Listing
January 2020

Percutaneous cardioplegic arrest before repeat sternotomy in patients with retrosternal aortic aneurysm.

J Thorac Cardiovasc Surg 2021 05 16;161(5):1724-1730. Epub 2019 Nov 16.

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objective: Redo sternotomy in patients with arterial cardiac structures adherent to the sternum carries a risk of catastrophic bleeding. In some of those cases, particularly if they have undergone multiple previous operations, deep hypothermic circulatory arrest alone may not provide sufficient time for a controlled dissection.

Methods: We present a series of 6 cases at risk for exsanguination during sternal re-entry successfully reoperated using percutaneous cardioplegic cardiac arrest induced before completed sternal re-entry to avoid or minimize the hypothermic circulatory arrest time.

Results: All patients survived their complex operations.

Conclusions: Percutaneous cardioplegic arrest allows safer repeat sternotomy in patients with arterial cardiac structures adherent to the sternum.
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http://dx.doi.org/10.1016/j.jtcvs.2019.09.191DOI Listing
May 2021

The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center.

Catheter Cardiovasc Interv 2020 08 12;96(2):442-447. Epub 2019 Nov 12.

Department of Cardiovascular Medicine, Cleveland Clinic, Heart and Vascular Institute, Cleveland, Ohio.

Introduction: Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose versus double Perclose for perclosure of large bore access during TAVR.

Methods: Patients undergoing Transfemoral (TF) TAVR from January 2014 to December 2017 within the Cleveland Clinic Aortic Valve Center were identified. A retrospective review of medical charts was conducted. Vascular complications were defined according to the VARC-2 criteria.

Results: A total of 740 patients were included; 487 (65.8%) received a single Perclose device while 253 (34.2%) received double Perclose devices. Baseline characteristics were similar with no differences between the single versus double Perclose groups, respectively. The access sheath size was similar in both groups with (14, 16, and 18 F) being the most common sizes utilized. Of the total 487 patients with single Perclose, 75.6% needed additional closure device (AngioSeal). With double Perclose strategy, additional closure device (AngioSeal) was used in 40.3% patients with 470 (63.5%) patients being successfully perclosed. Vascular complication rates including hematoma, stenosis requiring stenting, pseudoaneurysm, and other major vascular complications were similar between both groups.

Conclusion: Single 6F ProGlide use for preclosure is a safe strategy for TF TAVR using the S3 valve. Additional closure device was not needed in almost one-quarter of the patients. When necessary, residual bleeding can be controlled with the AngioSeal Device at the end of the procedure. This single device preclose strategy can help to reduce the cost of TAVR procedure without increasing risk.
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http://dx.doi.org/10.1002/ccd.28585DOI Listing
August 2020

Transcatheter innovations in tricuspid regurgitation: Navigate.

Prog Cardiovasc Dis 2019 Nov - Dec;62(6):493-495. Epub 2019 Nov 7.

Department of Thoracic & Cardiovascular Surgery, Cleveland Clinic - Heart & Vascular Institute, Cleveland, OH, USA. Electronic address:

Patients with isolated functional or recurrent tricuspid regurgitation are often considered high risk and denied surgery. There has been growing experience for transcatheter tricuspid valve implantation through valve-in-valve or valve-in-ring, and recently, but to a lesser extent, in native annulus. The NaviGate is a novel self-expanding valved-stent designed with unique features to treat tricuspid regurgitation, particularly, in the settings of severely dilated tricuspid annulus. Herein, we present the innovation facets and clinical application of the NaviGate system.
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http://dx.doi.org/10.1016/j.pcad.2019.11.004DOI Listing
March 2020

Unilateral Access Is Safe and Facilitates Peripheral Bailout During Transfemoral-Approach Transcatheter Aortic Valve Replacement.

JACC Cardiovasc Interv 2019 11;12(21):2210-2220

Heart and Vascular Institute, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objectives: The aim of this study was to compare the rate and trend of vascular complications when placing a second arterial sheath in the contralateral femoral artery during transcatheter aortic valve replacement (TAVR) unilaterally versus bilaterally.

Background: Vascular complications occur in approximately 5% to 8% of TAVR procedures. Many operators place a second arterial sheath in the contralateral femoral artery to perform aortic root angiography. The authors surmised that placing the second sheath ipsilateral and distal to the delivery sheath would be an easier option with similar safety.

Methods: The Cleveland Clinic Aortic Valve Center TAVR database was accessed, and data for patients undergoing transfemoral TAVR (TF-TAVR) from January 2014 to December 2017 were analyzed retrospectively. The primary outcome was the rate of peripheral vascular complications.

Results: A total of 1,208 patients who underwent TF-TAVR were included in this study. One thousand seven patients (83.36%) underwent bilateral femoral access, and 201 patients (16.64%) underwent TF-TAVR using a unilateral femoral approach. Over the study duration, use of the unilateral access approach trended upward significantly, reaching 43.7% of total cases in 2017. A gradual decline in access site-related vascular complications was observed, from 13.7% in 2014 to 7.4% in 2017. After propensity-score matching, peripheral vascular complications were similar between bilateral access and unilateral access (10.8% vs. 8.6%) (p = 0.543).

Conclusions: There was a significant decline in vascular complications from 2014 to 2017. Unilateral-access TF-TAVR provided similar safety compared with bilateral-access TF-TAVR and is a more accessible approach for managing access site-related complications and possibly achieving better patient satisfaction.
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http://dx.doi.org/10.1016/j.jcin.2019.06.050DOI Listing
November 2019

ECMO as a Bridge to Reoperative Cardiac Surgery in a Patient with Cardiogenic Shock and Severe Aortic Insufficiency Due to an Acute Aortic Valve Homograft Failure.

Heart Surg Forum 2019 07 2;22(4):E281-E282. Epub 2019 Jul 2.

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio, USA.

We report a 62-year-old male who had severe aortic insufficiency after a homograft root replacement, requiring venoarterial extracorporeal membrane oxygenation prior to surgery due to profound cardiogenic shock. Severe aortic insufficiency is a contraindication for venoarterial extracorporeal membrane oxygenation, but we were able to stabilize the patient and successfully perform an urgent reoperative surgery.
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http://dx.doi.org/10.1532/hsf.1758DOI Listing
July 2019

Long-term Outcomes of Surgery for Invasive Valvular Endocarditis Involving the Aortomitral Fibrosa.

Ann Thorac Surg 2019 11 27;108(5):1314-1323. Epub 2019 Jun 27.

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.

Background: Reconstruction of the intervalvular fibrosa (IVF) for invasive double-valve infective endocarditis (IE) is a technically challenging operation. This study presents the long-term outcomes of two surgical techniques for IVF reconstruction.

Methods: From 1988 to 2017, 138 patients with invasive double-valve IE underwent surgical reconstruction of the IVF, along with double-valve replacement (Commando procedure, n = 86) or aortic valve replacement with mitral valve repair (hemi-Commando procedure, n = 52). Mean follow-up was 41 ± 5.9 months.

Results: Reoperation was required in 82% of patients, and 34% underwent emergency surgery. Pathologic features included positive blood cultures (90%), prosthetic valve IE (75%), aortic root abscess (78%), mitral annular abscess (24%), and intracardiac fistula (12%). There were 28 hospital deaths: 21 (24%) in the Commando group and 7 (14%) in the hemi-Commando group (P = .12). Overall survival at 1, 5, and 10 years was 67%, 48%, and 37%, respectively. Coronary artery disease, native valve IE, and causative organism (Staphylococcus aureus, coagulase-negative Staphylococcus, and viridans streptococci) were risk factors for late mortality. Freedom from reoperation at 1, 5, and 8 years was 87%, 74%, and 55%, respectively. Freedom from recurrent IE at 1, 5, and 8 years was 90%, 78%, and 67%, respectively.

Conclusions: Although it is technically demanding, surgery for invasive IE involving IVF, which provides the only chance for cure, can be performed with reasonable clinical outcomes. In cases of IE invading the IVF and limited to the anterior mitral valve leaflet, a hemi-Commando procedure that includes mitral valve repair has improved early outcomes.
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http://dx.doi.org/10.1016/j.athoracsur.2019.04.119DOI Listing
November 2019

Value of perioperative inhaled epoprostenol with low tidal volume ventilation for complex endocarditis surgery.

J Card Surg 2019 Aug 18;34(8):676-683. Epub 2019 Jun 18.

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland, Ohio.

Background And Aim: To compare outcomes of patients treated with inhaled epoprostenol and low tidal volume ventilation during cardiopulmonary bypass with those who did not receive this medication in the operating room at all, and those who received it as a rescue therapy at the end of the case.

Methods: Retrospective chart review between 2014 and 2017, follow-up included the entire hospital stay.

Results: Seventy-one patients were included, and mean age was 54 years. 78.9% of the patients were male. Procedures included 96% (n = 68) aortic valve replacement, 28% (n = 20) reconstruction of the intravalvular fibrosa, and 13% (n = 9) repair of an endocarditis-related intracardiac fistula. Patients who received epoprostenol (iEpo) (treatment and rescue groups), when compared with the control group had more intra-aortic balloon pump placement (23% vs 2.5%, P = .018), open chest after surgery (32% vs 7.5%, P = .012), and duration of mechanical ventilation (8.3 ± 2.7 vs. 2.4 ± 0.4 days, P = 0.01). There was no significant difference between the two groups in terms of extracorporeal circulatory support (6.5% vs 2.5%, P = .577) and hospital death (13% vs 10%, P = .72). In a subanalysis, hospital death and duration of mechanical ventilation were higher in the recue group when compared with the treatment group (P = .004 and .056, respectively).

Conclusions: Prophylactic application of iEpo with low tidal volume ventilation for an anticipated complex endocarditis operation may contribute to favorable outcome when compared with postoperative epoprostenol rescue.
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http://dx.doi.org/10.1111/jocs.14095DOI Listing
August 2019

Prevalence of and Risk Factors for Permanent Pacemaker Implantation After Aortic Valve Replacement.

Ann Thorac Surg 2019 09 26;108(3):700-707. Epub 2019 Apr 26.

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: Damage to the cardiac conduction system requiring permanent pacemaker implantation is a complication of aortic valve replacement (AVR) that may importantly affect quality of life. We investigated the prevalence of and preprocedure risk factors for new permanent pacemakers after surgical (SAVR) and transcatheter AVR (TAVR) at a single institution.

Methods: Preoperative variables and baseline electrocardiograms were reviewed for 5807 patients undergoing elective SAVR, with or without coronary artery bypass grafting, and 1292 undergoing TAVR, with or without percutaneous coronary intervention, from 2006 to 2017 at Cleveland Clinic. Patients with previous permanent pacemakers were excluded. Risk factors for permanent pacemaker implantation were identified using multivariable logistic regression analysis.

Results: New permanent pacemakers were implanted in 151 (2.6%) after SAVR and in 125 (9.7%) after TAVR (whole group SAVR vs TAVR, P <.0001). Risk factors for pacemaker implantation after TAVR included preoperative conduction disturbances and type of prosthesis (SAPIEN, 9.5%; SAPIEN XT, 4.8%; SAPIEN 3, 10% [Edwards Lifesciences, Irvine, CA]; CoreValve, 30% [Medtronic, Minneapolis, MN]; and other TAVR, 10%). There were no reliable risk factors for pacemaker implantation after SAVR. Bicuspid valves, mechanical vs bioprosthetic valves, higher Society of Thoracic Surgeons risk score, and concomitant coronary artery bypass grafting were not associated with elevated risk.

Conclusions: At a high-volume institution in the current era, establishing a baseline for pacemaker implantation after AVR is necessary. Preoperative conduction disturbances and transcatheter valve type affect its prevalence. These data provide a benchmark that should be taken into account when considering TAVR in low-risk patients.
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http://dx.doi.org/10.1016/j.athoracsur.2019.03.056DOI Listing
September 2019

Cannulation strategies in acute type A dissection repair: A systematic axillary artery approach.

J Thorac Cardiovasc Surg 2019 09 19;158(3):647-659.e5. Epub 2018 Dec 19.

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio; Aorta Center, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objectives: Consensus regarding initial cannulation site for acute type A dissection repair is lacking. Objectives were to review our experience with systematic initial axillary artery cannulation, characterize patients on the basis of cannulation site, and assess outcomes.

Methods: From January 2000 to January 2017, 775 patients underwent emergency acute type A dissection repair. Initial axillary cannulation was performed in 617 (80%), femoral in 93 (12%), and central in 65 (8.4%). In-hospital mortality and stroke risk factors were identified using logistic regression.

Results: Reasons for selecting initial central or femoral instead of axillary cannulation included unsuitable axillary anatomy (n = 67; 42%), surgeon preference (n = 38; 24%), hemodynamic instability (n = 34; 22%), and preexisting cannulation (n = 19; 12%). Cannulation site was shifted or added intraoperatively in 82 (11%), with initial cannulation site being axillary (n = 23 of 617; 3.7%), central (6 of 65; 9.2%), or femoral (n = 53 of 93; 57%), for surgeon preference (n = 60; 73%), high flow resistance (n = 13; 16%), increased aortic false lumen flow (n = 6; 7.3%), and other (n = 3; 3.7%). In-hospital mortality was 8.6% (n = 67; lowest for axillary, 7.3% [P = .02]) and stroke 8.3% (n = 64). Hemodynamic instability (odds ratio [OR], 7.6; 95% confidence interval [CI], 4.2-14), limb ischemia (OR, 3.7; 95% CI, 1.5-9.3), stroke (OR, 5.5; 95% CI, 2.2-14), and aortic regurgitation (OR, 2.2; 95% CI, 1.2-4.2) at presentation were risk factors for mortality and central cannulation site (OR, 2.3; 95% CI, 1.05-5.1) and aortic stenosis (OR, 2.4; 95% CI, 1.2-4.6) for stroke.

Conclusions: Systematic initial axillary cannulation for acute type A dissection repair is safe and effective and can be tailored to patients' specific needs. With this strategy, comparable outcomes are observed among cannulation sites and are largely determined according to patient presentation rather than cannulation site.
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http://dx.doi.org/10.1016/j.jtcvs.2018.11.137DOI Listing
September 2019

Advances in managing the noninfected open chest after cardiac surgery: Negative-pressure wound therapy.

J Thorac Cardiovasc Surg 2019 05 27;157(5):1891-1903.e9. Epub 2018 Nov 27.

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objective: The objective of this study was to compare safety and clinical effectiveness of negative-pressure wound therapy (NPWT) with traditional wound therapy for managing noninfected open chests with delayed sternal closure after cardiac surgery.

Methods: From January 2000 to July 2015, 452 of 47,325 patients who underwent full sternotomy left the operating room with a noninfected open chest (0.96%), managed using NPWT in 214-with frequency of use rapidly increasing to near 100%-and traditionally in 238. Predominant indications for open-chest management were uncontrolled coagulopathy or hemodynamic compromise on attempted chest closure. Weighted propensity-score matching was used to assess in-hospital complications and time-related survival.

Results: NPWT and traditionally managed patients had similar high-risk preoperative profiles. Most underwent reoperations (63% of the NPWT group and 57% of the traditional group), and 21% versus 25% were emergency procedures. Reexplorations for bleeding were less common with NPWT versus traditional wound therapy (n = 63 [29%] vs 104 [44%], P = .002). Median duration of open-chest to definitive sternal closure was 3.5 days for NPWT versus 3.1 for traditionally managed patients (P[log rank] = .07). Seven patients (3.3%) were converted from NPWT to traditional therapy because of hemodynamic intolerance and 6 (2.5%) from traditional to NPWT. No NPWT-related cardiovascular injuries occurred. Among matched patients, NPWT was associated with better early survival (61% vs 44% at 6 months; P = .02).

Conclusions: NPWT is safe and effective for managing noninfected open chests after cardiac surgery. By facilitating open-chest management and potentially improving outcomes, it has become our therapy of choice and perhaps has lowered our threshold for leaving the chest open after cardiac surgery.
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http://dx.doi.org/10.1016/j.jtcvs.2018.10.152DOI Listing
May 2019

Transcatheter Tricuspid Valve Replacement for Treating Severe Tricuspid Regurgitation: Initial Experience With the NaviGate Bioprosthesis.

Can J Cardiol 2018 10 6;34(10):1370.e5-1370.e7. Epub 2018 Aug 6.

Quebec Heart & Lung Institute, Laval University, Québec City, Québec, Canada. Electronic address:

Despite the growing evidence with emerging transcatheter tricuspid valve repair therapies, the experience with transcatheter tricuspid valve replacement remains sparse. We describe a case of severe tricuspid regurgitation in a 79-year-old patient deemed unsuitable for isolated tricuspid valve surgery, successfully treated with a 40-mm self-expandable NaviGate (NaviGate Cardiac Structures, Inc, Lake Forest, CA) valved stent via a transatrial approach, with excellent result and hemodynamic performance at 4 months.
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http://dx.doi.org/10.1016/j.cjca.2018.07.481DOI Listing
October 2018

Transcatheter Tricuspid Valve Implantation of NaviGate Bioprosthesis in a Preclinical Model.

JACC Basic Transl Sci 2018 Feb 24;3(1):67-79. Epub 2018 Jan 24.

NaviGate Cardiac Structures, Inc., Lake Forest, California.

Patients with isolated functional or recurrent tricuspid regurgitation are often denied surgery because they are considered to be at high risk. Transcatheter valve therapy provides a less invasive alternative for tricuspid regurgitation associated with right heart failure. We have evaluated the feasibility of transcatheter tricuspid valve implantation of the NaviGate valved stent in a long-term swine model. The valved stent was successfully implanted through transjugular and transatrial approaches on the beating heart with excellent hemodynamic and valve performance. No conduction disturbance or coronary obstruction was observed. This technology could provide an alternative treatment for patients who are at high surgical risk with severe tricuspid regurgitation and compromised right ventricular function.
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http://dx.doi.org/10.1016/j.jacbts.2017.08.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6058955PMC
February 2018

Transcatheter Tricuspid Valve Interventions: Landscape, Challenges, and Future Directions.

J Am Coll Cardiol 2018 06;71(25):2935-2956

Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada. Electronic address:

Tricuspid regurgitation is a common finding in patients with left-sided valvular or myocardial disease, often being a marker for late-stage chronic heart failure with a grim prognosis. However, isolated tricuspid valve surgery remains infrequent and is associated with the highest mortality among all valve procedures. Hence, a largely unmet clinical need exists for less invasive therapeutic options in these patients. In recent times, multiple percutaneous therapies have been developed for treating severe tricuspid regurgitation, including tricuspid valve repair and, more recently replacement, opening an entirely new venue for managing tricuspid regurgitation. The aim of this review is to provide an updated overview and a clinical perspective on novel transcatheter tricuspid valve therapies, highlighting potential challenges and future directions.
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http://dx.doi.org/10.1016/j.jacc.2018.04.031DOI Listing
June 2018

Pitfalls and Pearls for 3-Dimensional Printing of the Tricuspid Valve in the Procedural Planning of Percutaneous Transcatheter Therapies.

JACC Cardiovasc Imaging 2018 10 13;11(10):1531-1534. Epub 2018 Jun 13.

Department of Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.

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http://dx.doi.org/10.1016/j.jcmg.2018.05.003DOI Listing
October 2018

Simple versus complex degenerative mitral valve disease.

J Thorac Cardiovasc Surg 2018 07 4;156(1):122-129.e16. Epub 2018 Apr 4.

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objectives: At a center where surgeons favor mitral valve (MV) repair for all subsets of leaflet prolapse, we compared results of patients undergoing repair for simple versus complex degenerative MV disease.

Methods: From January 1985 to January 2016, 6153 patients underwent primary isolated MV repair for degenerative disease, 3101 patients underwent primary isolated MV repair for simple disease (posterior prolapse), and 3052 patients underwent primary isolated MV repair for complex disease (anterior or bileaflet prolapse), based on preoperative echocardiographic images. Logistic regression analysis was used to generate propensity scores for risk-adjusted comparisons (n = 2065 matched pairs). Durability was assessed by longitudinal recurrence of mitral regurgitation and reoperation.

Results: Compared with patients with simple disease, those undergoing repair of complex pathology were more likely to be younger and female (both P values < .0001) but with similar symptoms (P = .3). The most common repair technique was ring/band annuloplasty (3055/99% simple vs 3000/98% complex; P = .5), followed by leaflet resection (2802/90% simple vs 2249/74% complex; P < .0001). Among propensity-matched patients, recurrence of severe mitral regurgitation 10 years after repair was 6.2% for simple pathology versus 11% for complex pathology (P = .007), reoperation at 18 years was 6.3% for simple pathology versus 11% for complex pathology, and 20-year survival was 62% for simple pathology versus 61% for complex pathology (P = .6).

Conclusions: Early surgical intervention has become more common in patients with degenerative MV disease, regardless of valve prolapse complexity or symptom status. Valve repair was associated with similarly low operative risk and time-related survival but less durability in complex disease. Lifelong annual echocardiographic surveillance after MV repair is recommended, particularly in patients with complex disease.
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http://dx.doi.org/10.1016/j.jtcvs.2018.02.102DOI Listing
July 2018

Reply.

Ann Thorac Surg 2018 03;105(3):986

Department of Thoracic and Cardiovascular Surgery, Department of Quantitative Health Sciences, Cleveland Clinic, 9500 Euclid Ave, Desk J4-1, Cleveland, OH 44143. Electronic address:

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http://dx.doi.org/10.1016/j.athoracsur.2017.10.010DOI Listing
March 2018

The incorporated aortomitral homograft for double-valve endocarditis: the 'hemi-Commando' procedure. Early and mid-term outcomes.

Eur J Cardiothorac Surg 2018 05;53(5):1055-1061

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland, OH, USA.

Objectives: Surgical management of invasive double-valve infective endocarditis (IE) involving the intervalvular fibrosa (IVF) is a technical challenge that requires extensive debridement followed by complex reconstruction. In this study, we present the early and mid-term outcomes of the hemi-Commando procedure and aortic root replacement with reconstruction of IVF using an aortomitral allograft.

Methods: From 2010 to 2017, 37 patients with IE involving the IVF underwent the hemi-Commando procedure. Postoperative clinical data and echocardiograms were reviewed for the assessment of cardiac structural integrity and clinical outcomes.

Results: Twenty-nine (78%) cases were redo surgery and 15 (41%) were emergency surgery. Preoperatively, 70% (n = 26) of patients were admitted to the intensive care unit and 11% (n = 4) of patients were in septic shock. Ten (27%) patients had native aortic valve IE, while 27 (73%) patients had prosthetic valve IE. Hospital death occurred in 8% (n = 3) of patients due to multisystem organ failure. Postoperative echocardiogram showed no aortic regurgitation in 86% (n = 32) and mild regurgitation in 14% (n = 5) of patients, while mitral regurgitation prevalence was none/trivial in 62% (n = 23), mild in 32% (n = 12) and moderate in 5%. Intact IVF reconstruction was confirmed in all patients with no abnormal communication between the left heart chambers. One-year survival was 91%, while 3-year survival was 82%. Mid-term follow up revealed 1 death secondary to recurrent IE.

Conclusions: Compared to double-valve replacement with IVF reconstruction ('Commando operation'), the early and mid-term outcomes of the hemi-Commando procedure proved to be a feasible treatment option for IVF reconstruction, enabling preservation of the mitral valve and the subvalvular apparatus in high-risk patients with invasive double-valve IE.
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http://dx.doi.org/10.1093/ejcts/ezx439DOI Listing
May 2018

First-in-Human Implantations of the NaviGate Bioprosthesis in a Severely Dilated Tricuspid Annulus and in a Failed Tricuspid Annuloplasty Ring.

Circ Cardiovasc Interv 2017 12;10(12)

From the Departments of Thoracic and Cardiovascular Surgery (J.L.N., H.E., S.U., S.M., A.M.G., L.G.S.) and Cardiovascular Medicine (S.K., S.C.H., A.K., L.R., D.H.), Cleveland Clinic, OH.

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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.117.005840DOI Listing
December 2017

Rarity of invasiveness in right-sided infective endocarditis.

J Thorac Cardiovasc Surg 2018 01 16;155(1):54-61.e1. Epub 2017 Aug 16.

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Research Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objective: The rarity of invasiveness of right-sided infective endocarditis (IE) compared with left-sided has not been well recognized and evaluated. Thus, we compared invasiveness of right- versus left-sided IE in surgically treated patients.

Patients And Methods: From January 2002 to January 2015, 1292 patients underwent surgery for active IE, 138 right-sided and 1224 left-sided. Among patients with right-sided IE, 131 had tricuspid and 7 pulmonary valve IE; 12% had prosthetic valve endocarditis. Endocarditis-related invasiveness was based on echocardiographic and operative findings.

Results: Invasive disease was rare on the right side, occurring in 1 patient (0.72%; 95% confidence interval 0.02%-4.0%); rather, it was limited to valve cusps/leaflets or was superficial. In contrast, IE was invasive in 408 of 633 patients with aortic valve (AV) IE (65%), 113 of 369 with mitral valve (MV) IE (31%), and 148 of 222 with AV and MV IE (67%). Staphylococcus aureus was a more predominant organism in right-sided than left-sided IE (right 40%, AV 19%, MV 29%), yet invasion was observed almost exclusively on the left side of the heart, which was more common and more severe with AV than MV IE and more common with prosthetic valve endocarditis than native valve IE.

Conclusions: Rarity of right-sided invasion even when caused by S aureus suggests that invasion and development of cavities/"abscesses" in patients with IE may be driven more by chamber pressure than organism, along with other reported host-microbial interactions. The lesser invasiveness of MV compared with AV IE suggests a similar mechanism: decompression of MV annulus invasion site(s) toward the left atrium.
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http://dx.doi.org/10.1016/j.jtcvs.2017.07.068DOI Listing
January 2018

Open Distal Fenestration of Chronic Dissection Facilitates Endovascular Elephant Trunk Completion: Late Outcomes.

Ann Thorac Surg 2017 Dec 19;104(6):1960-1967. Epub 2017 Sep 19.

Aorta Center, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio; Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio. Electronic address:

Background: Retrograde false lumen perfusion is a common mode of failure after stent grafting chronic aortic dissection. Open fenestration during the first-stage elephant trunk (ET) creates a landing zone for second-stage endovascular ET completion in patients with a false lumen aneurysm. Our objectives were to assess long-term safety and durability of this technique.

Methods: From 2007 to 2014, 56 patients with thoracoabdominal dissection and aneurysm underwent stage 1 ET and open fenestration. Fifteen (26.8%) patients had DeBakey type III dissection, and 41 (73%) had type I, 38 (68%) with previous ascending repair. Mean maximum diameter was 5.8 ± 1 cm. Imaging follow-up was complete in all survivors.

Results: Endovascular ET completion was performed in 49 patients (87.5%), urgently in 11 (22%). Operative mortality after the first stage was 1.8%. The ET in 8 patients was performed prophylactically. Complications after the first stage included transient ischemic attack in 1 patient (1.8%), subdural hemorrhage in 1 (1.8%), tracheostomy in 1 (1.8%), bleeding in 5 (8.9%), and paraplegia in 1 (1.8%). All 48 patients had false lumen thrombosis in the treated segment without endoleak or retrograde perfusion. The aneurysm sac shrunk in 67%, with a mean overall aortic diameter reduction of 1 ± 0.8 cm. Median follow-up was 33.8 months. Eight patients (16%) underwent 11 late reinterventions, comprising thoracic endovascular aortic repair extension in 4 patients (36%), thoracic endovascular aortic repair and false lumen embolization in 3 (27%), open thoracoabdominal aortic aneurysm completion repair in 2 (18%), and redo proximal repair for infection in 2 (18%). There were 6 late deaths.

Conclusions: Open aortic fenestration to create a distal landing zone during stage 1 ET facilitates endovascular completion for chronic dissection with false lumen aneurysm. The technique is safe, effective, and durable. It promotes reverse aortic remodeling and eliminates retrograde false lumen flow.
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http://dx.doi.org/10.1016/j.athoracsur.2017.05.044DOI Listing
December 2017

Transcatheter mitral valve replacement with the NaviGate stent in a preclinical model.

EuroIntervention 2017 12 8;13(12):e1401-e1409. Epub 2017 Dec 8.

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH, USA.

Aims: The aim of this study was to test the feasibility of transcatheter mitral valve implantation of the NaviGate device in acute and chronic preclinical models.

Methods And Results: We evaluated NaviGate valved stent implantation in the mitral position in an acute swine model (n=24, ≤5 days) through three different approaches - transatrial, transapical, and transseptal - and in a chronic swine model (n=12, >10 days) through a transatrial approach. The NaviGate implantation procedures were successful in 83% of the acute model studies (n=20) and 83% of the chronic model studies (n=10). Echocardiographic assessment showed low gradient across the valved stent (mean gradient <3 mmHg) and the left ventricular outflow tract (mean gradient <6 mmHg). Post implantation, there was no mitral regurgitation (MR) in 75% (n=15) of the acute studies and mild MR in 25% (n=5). In the chronic model, there was no MR in 60% (n=6) and mild MR in 40% (n=4). The implantation procedure was aborted in four acute studies due to inferior vena cava injury and in two chronic studies due to prosthesis-annulus mismatch.

Conclusions: In preparation for clinical application, transcatheter mitral implantation of the NaviGate valved stent was proved feasible in acute and chronic preclinical models. The three featured delivery approaches are of particular value for high-risk patients with functional MR and challenging vascular access.
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http://dx.doi.org/10.4244/EIJ-D-17-00210DOI Listing
December 2017
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