Less invasive surgical implant strategy and right heart failure after LVAD implantation

doi:10.1016/j.healun.2021.01.005

The Journal of Heart and Lung Transplantation

Volume 40, Issue 4, April 2021, Pages 289-297

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https://doi.org/10.1016/j.healun.2021.01.005 Get rights and content

BACKGROUND

Conventional median sternotomy (CMS) is still the standard technique utilized to implant left ventricular assist devices (LVADs). Recent studies suggest that less invasive surgery (LIS) may be beneficial; however, robust data on differences in right heart failure (RHF) are lacking. This study aimed to determine the impact of LIS compared with that of CMS on RHF outcomes after LVAD implantation.

METHODS

An international multicenter retrospective cohort study was conducted across 5 centers. Patients were grouped according to their implantation technique (LIS vs CMS). Only centrifugal devices were included. RHF was defined as severe or severe acute RHF according to the 2013 Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definition. Logistic multivariate regression and propensity score‒matched analyses were performed to account for confounding.

RESULTS

Overall, 427 implantations occurred during the study period, with 305 patients implanted using CMS and 122 using LIS. Pre-operative extracorporeal membrane oxygenation (ECMO) and intra-aortic balloon pump (IABP) use was more common in the CMS group; off-pump implantation was more common in the LIS group. Other pre-implant variables, including age, creatinine, hemodynamics, and tricuspid regurgitation, did not differ between the 2 groups. Post-operative RHF was less common in the patients who underwent LIS than in those who underwent CMS as was post-operative right ventricular assist device (RVAD) use. LIS remained associated with less RHF in the multivariate analysis. After propensity score matching conditional for age, sex, INTERMACS profile, ECMO, and IABP use in a ratio of 2:1 (CMS to LIS), RHF (29.9% vs 18.6%, p = 0.001) and the need for post-operative RVAD (18.6% vs 8.2%; p = 0.009) remained more common in the CMS group than in the LIS group. There were no significant differences in survival up to 1 year between the groups.

CONCLUSIONS

LIS may be associated with less RHF after LVAD implantation compared with CMS. Despite the possible reduction in RHF, there was no difference in 1-year survival. LIS is an alternative to traditional CMS.

Section snippets

Study design

A multicenter retrospective cohort study was conducted across 5 centers, including the University Hospital of Düsseldorf (Düsseldorf, Germany) (n = 121), the Leipzig Heart Center (Germany) (n = 201), the University of Minnesota Medical Center (Minneapolis, MN) (n = 38), the Medical University of South Carolina (Charleston, SC) (n = 10), and the Johns Hopkins School of Medicine (Baltimore, MD) (n = 57). The study included 427 patients (aged >18 years) who underwent LVAD implantation between

Study population

Overall, 427 patients underwent an LVAD implantation; 305 implantations were performed through CMS and 122 by LIS. The CMS group consisted of 140 HM3 and 165 HVADs compared with 46 HM3 and 76 HVADs in the LIS group. There was no difference in the mean age, sex, body mass index, history of diabetes mellitus, or history of hypertension when comparing the patients in the CMS group with those in the LIS group. In addition, there was no significant difference in the baseline hemodynamic parameters

Discussion

This study represents the largest multicenter effort to compare CMS with LIS and their associations with RHF. We show that a less invasive LVAD implant strategy may be associated with a fewer instances of RHF. Although RHF was associated with excess mortality, all-cause mortality was not different between CMS and LIS groups in up to 1-year follow-up. In total, these data support an LIS strategy as an alternative to CMS implantation.

When considering a right ventricular (RV)-protective strategy,

Disclosure statement

R.C. reports no direct conflicts of interest relevant to this manuscript. Other general conflicts include serving on a speaker's bureau for Abbott and on the heart failure advisory board for Medtronic. Her spouse is employed by Medtronic. R.J. reports no direct conflicts of interest relevant to this manuscript. Other general conflicts include serving as a consultant to Medtronic and Abbott. L.L. reports no direct conflicts of interest relevant to this manuscript. Other general conflicts include

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Acute right ventricular geometric change predicts outcomes in HeartMate 3 patients
2024, Journal of Heart and Lung Transplantation
The physiological response of the right ventricle (RV) following left ventricular assist device (LVAD) implantation is difficult to predict. We aimed to investigate RV geometric and functional changes after LVAD insertion and their effects on clinical outcomes.
We retrospectively reviewed 188 patients who underwent HeartMate 3 implantation at our center between November 2014 and September 2021. The RV end-diastolic diameter (RVEDD) and RV end-diastolic area (RVEDA) were measured on preoperative and predischarge transthoracic echocardiography. The nonadapted group included patients with increased RVEDD and RVEDA at discharge. The composite outcome was defined as death or readmission due to worsening right heart failure.
There were 82 patients (44%) who had a nonadapted and 106 patients (56%) who had an adapted RV. Preoperatively, the nonadapted group had smaller RVEDD (46 vs 49 mm, p < 0.001) and RVEDA (27 vs 31 cm², p < 0.001). At discharge, the nonadapted group had larger RVEDD (51 vs 43 mm, p < 0.001) and RVEDA (33 vs 27 cm², p < 0.001). Kaplan-Meier analysis demonstrated worse 3-year survival (77% vs 91%, p = 0.006) and freedom from composite outcome (58% vs 85%, p < 0.001) in the nonadapted group. A multivariable Cox proportional hazards model showed that nonadaption (hazard ratio [HR] 3.09, 95% confidence interval [CI] 1.29-7.40, p = 0.01) and age (HR 3.73, 95% CI 1.42-9.77, p = 0.007) were independent predictors of composite outcome.
Acute RV dimensional changes after LVAD insertion may represent intrinsic RV function and may be a useful prognostic marker.
Occult right ventricular dysfunction and right ventricular-vascular uncoupling in left ventricular assist device recipients
2024, Journal of Heart and Lung Transplantation
Detecting right heart failure post left ventricular assist device (LVAD) is challenging. Sensitive pressure-volume loop assessments of right ventricle (RV) contractility may improve our appreciation of post-LVAD RV dysfunction.
Thirteen LVAD patients and 20 reference (non-LVAD) subjects underwent comparison of echocardiographic, right heart cath hemodynamic, and pressure-volume loop-derived assessments of RV contractility using end-systolic elastance (Ees), RV afterload by effective arterial elastance (Ea), and RV-pulmonary arterial coupling (ratio of Ees/Ea).
LVAD patients had lower RV Ees (0.20 ± 0.08 vs 0.30 ± 0.15 mm Hg/ml, p = 0.01) and lower RV Ees/Ea (0.37 ± 0.14 vs 1.20 ± 0.54, p < 0.001) versus reference subjects. Low RV Ees correlated with reduced RV septal strain, an indicator of septal contractility, in both the entire cohort (r = 0.68, p = 0.004) as well as the LVAD cohort itself (r = 0.78, p = 0.02). LVAD recipients with low RV Ees/Ea (below the median value) demonstrated more clinical heart failure (71% vs 17%, p = 0.048), driven by an inability to augment RV Ees (0.22 ± 0.11 vs 0.19 ± 0.02 mm Hg/ml, p = 0.95) to accommodate higher RV Ea (0.82 ± 0.38 vs 0.39 ± 0.08 mm Hg/ml, p = 0.002). Pulmonary artery pulsatility index (PAPi) best identified low baseline RV Ees/Ea (≤0.35) in LVAD patients ((area under the curve) AUC = 0.80); during the ramp study, change in PAPi also correlated with change in RV Ees/Ea (r = 0.58, p = 0.04).
LVAD patients demonstrate occult intrinsic RV dysfunction. In the setting of excess RV afterload, LVAD patients lack the RV contractile reserve to maintain ventriculo-vascular coupling. Depression in RV contractility may be related to LVAD left ventricular unloading, which reduces septal contractility.
Less is better? Comparing effects of median sternotomy and thoracotomy surgical approaches for left ventricular assist device implantation on postoperative outcomes and valvulopathy
2024, Journal of Thoracic and Cardiovascular Surgery
Citation Excerpt :
RHF is a major cause of morbidity and mortality after LVAD implantation, occurring in 10% to 40% of cases.24 A recent multicenter study by Saeed and colleagues6 demonstrated decreased incidence of RHF after less-invasive LVAD implantation compared with MS. Previous studies have also shown a decreased in RV failure associated with less-invasive implantation techniques.25-27 Although the mechanism of this protective effect is not fully understood, it is hypothesized to be related to the preservation of the pericardium, which helps maintain normal RV geometry, limit dilatation, and, in allowing the heart to remain in its native anatomic position, reduce the risk of RV free-wall tethering and hypoperfusion.6,27,28
Our objective was to compare outcomes after left ventricular assist device implantation performed via median sternotomy or lateral thoracotomy.
We retrospectively analyzed 222 adult patients with the HeartMate3 (Abbott Lab) left ventricular assist device implanted between November 2014 and November 2021. Outcomes stratified by surgical approach were evaluated in propensity score–matched groups. The primary outcome was 1-year survival. Secondary outcomes included in-hospital morbidity and mortality, readmissions, and significant valvular regurgitation.
Our cohort consisted of 60 patients (27%) who underwent lateral thoracotomy and 162 patients (73%) who underwent median sternotomy. Propensity score matching compared 45 patients who underwent lateral thoracotomy with 68 patients who underwent median sternotomy. There were no differences in intensive care unit or hospital stay duration (median, 10 vs 11 days, P = .58; 46 vs 40 days, P = .279), time to extubation (median, 2 days, P = .627), vasoactive-inotropic scores at intensive care unit arrival (18.20 vs 16.60, P = .654), or in-hospital mortality (2 [5%] vs 4 [6.1%] patients, P = 1). One-year survival (95.56% vs 90.61%, P = .48) and all-cause hospital readmission rate (Gray's test: P = .532) were also comparable. Patients who underwent lateral thoracotomy had significantly less early right ventricular failure (24.4% vs 53.7%, P = .004), although they had more follow-up tricuspid regurgitation (17.6% vs 0%, P = .030) and volume overload readmissions (Gray's test: P = .0005).
Our data suggest that lateral thoracotomy is a safe although not necessarily superior alternative to median sternotomy for HeartMate 3 implantation in the perioperative and postoperative periods, because it precludes concomitant tricuspid valve repairs and may be associated with increased risk of late tricuspid regurgitation and volume overload readmissions.
Ventricular assist device using a thoracotomy-based implant technique: Multi-Center Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy (HM3 SWIFT)
2024, Journal of Thoracic and Cardiovascular Surgery
The HeartMate 3 (Abbott) left ventricular assist device provides substantial improvement in long-term morbidity and mortality in patients with advanced heart failure. The Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study compares thoracotomy-based implantation clinical outcomes with standard median sternotomy.
We conducted a prospective, multicenter, single-arm study in patients eligible for HeartMate 3 implantation with thoracotomy-based surgical technique (bilateral thoracotomy or partial upper sternotomy with left thoracotomy). The composite primary end point was survival free of disabling stroke (modified Rankin score >3), or reoperation to remove or replace a malfunctioning device, or conversion to median sternotomy at 6-months postimplant (elective transplants were treated as a success). The primary end point (noninferiority, −15% margin) was assessed with >90% power compared with a propensity score-matched cohort (ratio 1:2) derived from the Multi-Center Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 continued access protocol.
The study enrolled 102 patients between December 2020 and July 2022 in the thoracotomy-based arm at 23 North American centers. Follow-up concluded in December 2022. In the Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical Techniques Other Than Full Median Sternotomy study group, noninferiority criteria was met (absolute between-group difference, −1.2%; Farrington Manning lower 1-sided 95% CI, −9.3%; P < .0025) and event-free survival was not different (85.0% vs 86.2%; hazard ratio, 1.01; 95% CI, 0.58-2.10). Length of stay with thoracotomy-based implant was longer (median, 20 vs 17 days; P = .03). No differences were observed for blood product utilization, adverse events (including right heart failure), functional status, and quality of life between cohorts.
Thoracotomy-based implantation of the HeartMate 3 left ventricular assist device is noninferior to implantation via standard full sternotomy. This study supports thoracotomy-based implantation as an additional standard for surgical implantation of the HeartMate 3 left ventricular assist device.
Durable Mechanical Circulatory Support: JACC Scientific Statement
2023, Journal of the American College of Cardiology
Despite advances in medical therapy for patients with stage C heart failure (HF), survival for patients with advanced HF is <20% at 5 years. Durable left ventricular assist device (dLVAD) support is an important treatment option for patients with advanced HF. Innovations in dLVAD technology have reduced the risk of several adverse events, including pump thrombosis, stroke, and bleeding. Average patient survival is now similar to that of heart transplantation at 2 years, with 5-year dLVAD survival now approaching 60%. Unfortunately, greater adoption of dLVAD therapy has not been realized due to delayed referral of patients to advanced HF centers, insufficient clinician knowledge of contemporary dLVAD outcomes (including gains in quality of life), and deprioritization of patients with dLVAD support waiting for heart transplantation. Despite these challenges, novel devices are on the horizon of clinical investigation, offering smaller size, permitting less invasive surgical implantation, and eliminating the percutaneous lead for power supply.
Late Right Heart Failure After Left Ventricular Assist Device Implantation: Contemporary Insights and Future Perspectives
2023, JACC: Heart Failure
Late right heart failure (RHF) is increasingly recognized in patients with long-term left ventricular assist device (LVAD) support and is associated with decreased survival and increased incidence of adverse events such as gastrointestinal bleeding and stroke. Progression of right ventricular (RV) dysfunction to clinical syndrome of late RHF in patients supported with LVAD is dependent on the severity of pre-existing RV dysfunction, persistent or worsening left- or right-sided valvular heart disease, pulmonary hypertension, inadequate or excessive left ventricular unloading, and/or progression of the underlying cardiac disease. RHF likely represents a continuum of risk with early presentation and progression to late RHF. However, de novo RHF develops in a subset of patients leading to increased diuretic requirement, arrhythmias, renal and hepatic dysfunction, and heart failure hospitalizations. The distinction between isolated late RHF and RHF due to left-sided contributions is lacking in registry studies and should be the focus of future registry data collection. Potential management strategies include optimization of RV preload and afterload, neurohormonal blockade, LVAD speed optimization, and treatment of concomitant valvular disease. In this review, the authors discuss definition, pathophysiology, prevention, and management of late RHF.

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Less invasive surgical implant strategy and right heart failure after LVAD implantation

BACKGROUND

METHODS

RESULTS

CONCLUSIONS

Section snippets

Study design

Study population

Discussion

Disclosure statement

J Heart Lung Transplant

Ann Thorac Surg

J Heart Lung Transplant

J Heart Lung Transplant

J Heart Lung Transplant

J Heart Lung Transplant

J Heart Lung Transplant

Semin Thorac Cardiovasc Surg

J Thorac Cardiovasc Surg

J Heart Lung Transplant

Chest