Permanent Pacemaker Implantation and Long-Term Outcomes of Patients Undergoing Concomitant Mitral and Tricuspid Valve Surgery.

BACKGROUND: Tricuspid valve annuloplasty (TA) during mitral valve repair (MVr) is associated with increased risk of permanent pacemaker (PPM) implantation, but the magnitude of risk and long-term clinical consequences have not been firmly established. OBJECTIVES: This study assesses the incidence rates of PPM implantation after isolated MVr and following MVr with TA as well as the associated long-term clinical consequences of PPM implantation. METHODS: State-mandated hospital discharge databases of New York and California were queried for patients undergoing MVr (isolated or with concomitant TA) between 2004 and 2019. Patients were stratified by whether or not they received a PPM within 90 days of index surgery. After weighting by propensity score, survival, heart failure hospitalizations (HFHs), endocarditis, stroke, and reoperation were compared between patients with or without PPM. RESULTS: A total of 32,736 patients underwent isolated MVr (n = 28,003) or MVr + TA (n = 4,733). Annual MVr + TA volumes increased throughout the study period (P < 0.001, trend), and PPM rates decreased (P < 0.001, trend). The incidence of PPM implantation <90 days after surgery was 7.7% for MVr and 14.0% for MVr + TA. In 90-day conditional landmark-weighted analyses, PPMs were associated with reduced long-term survival among MVr (HR: 1.96; 95% CI: 1.75-2.19; P < 0.001) and MVr + TA recipients (HR: 1.65; 95% CI: 1.28-2.14; P < 0.001). In both surgical groups, PPMs were also associated with an increased risk of HFH (HR: 1.56; 95% CI: 1.27-1.90; P < 0.001) and endocarditis (HR: 1.95; 95% CI: 1.52-2.51; P < 0.001), but not with stroke or reoperation. CONCLUSIONS: Compared to isolated MVr, adding TA to MVr was associated with a higher risk of 90-day PPM implantation. In both surgical groups, PPM implantation was associated with an increase in mortality, HFH, and endocarditis.

Pacemaker implantation associated with tricuspid repair in the setting of mitral valve surgery: Insights from a Cardiothoracic Surgical Trials Network randomized trial.

OBJECTIVES: In a recent trial, tricuspid annuloplasty (TA) during mitral valve surgery (MVS) for degenerative mitral regurgitation and moderate or less tricuspid regurgitation (TR) reduced the composite rate of death, reoperation for TR, or TR progression at 2 years. However, this benefit was counterbalanced by an increase in implantation of permanent pacemakers (PPMs). In this study, we analyzed the timing, indications, and risk factors for these implantations. METHODS: We randomized 401 patients (MVS alone = 203; MVS + TA = 198). Potential risk factors for PPMs were assessed using multivariable time-to-event models with death and PPM implantation for heart failure indications as competing risks. RESULTS: A PPM was implanted in 36 patients (9.6; 95% CI, 6.8-13.0) within 2 years of randomization, with 30/187 (16.0%) in the MVS + TA and 6/188 (3.2%) in the MVS groups (rate ratio, 5.08; 95% CI, 2.16-11.94; P < .001). Most (29/36; 80.6%) implantations occurred within 30 days postoperatively. Independent risk factors for PPM implantation within 2 years were TA (hazard ratio [HR], 5.94; 95% CI, 2.27-15.53; P < .001), increasing age (5 years, HR, 1.23; 95% CI, 1.01-1.52; P = .04), and left ventricular ejection fraction (LVEF; HR, 0.96; 95% CI, 0.92-0.99; P = .02). In the subset of TA recipients (n = 197), age (5 years, HR, 1.05; 95% CI, 1.00-1.10; P = .04) and LVEF (HR, 0.95; 95% CI, 0.91-0.99; P = .01) were associated with PPM within 2 years. CONCLUSIONS: Concomitant TA, age, and baseline LVEF were risk factors for PPM implantation in patients who underwent MVS for degenerative mitral regurgitation. Although TA was effective in preventing progression of TR, innovation is needed to identify ways to decrease PPM implantation rates.

Ethics in humanitarian efforts: giving due credit to the local team.

BACKGROUND: It has become increasingly apparent that only the truly effective humanitarian work emphasises empowering local practitioners. One problem, though, is that we are often seen as the "experts" who have come to "save" the children. This perception may adversely affect the confidence in the country's own providers. METHODS: Non-profit organisations performing paediatric heart surgery in developing countries were identified from two sources: the CTSnet "volunteerism" web page and an Internet search using the term "Pediatric Heart Surgery Medical Mission." The website of each organisation was reviewed, seeking a "purpose" or "mission" statement or summary of the organisation's work. A separate Internet search of news articles was performed. The top five articles were analysed for each organisation, and the findings are then analysed using the Principlist and Utilitarian ethical systems. RESULTS: A total of 10 separate non-profit organisations were identified. The websites of eight (80%) placed significant emphasis on the educational aspects of their work and/or on interaction with local professionals. However, of 43 news articles reviewed, reporters mentioned education of, or interaction with, local professionals in only 14 (33%), and four out of 10 organisations studied had no mention of the local providers in any article. CONCLUSIONS: Although non-profit organisations emphasise the teaching and programme-building aspects of their efforts, media reports largely focus on simpler and more emotional stories such as patient successes or large donations. Acknowledgement of the clinical and financial contributions of the host countries is both a duty following from the principle of justice and an important factor in long-term programme building.

Ethics in humanitarian efforts: when should resources be allocated to paediatric heart surgery?

BACKGROUND: In countries with ample resources, no debate exists as to whether heart surgery should be provided. However, where funding is limited, what responsibility exists to care for children with congenital heart defects? If children have a "right" to surgical treatment, to whom is the "duty" to provide it assigned? These questions are subjected to ethical analysis. METHODS: Examination is initially based on the four principles of medical ethics: autonomy, beneficence, non-maleficence, and justice. Consideration of beneficence and justice is expanded using a consequentialist approach. RESULTS: Social structures, including governments, exist to foster the common good. Society, whether by means of government funding or otherwise, has the responsibility, according to the means available, to assure health care for all based on the principles of beneficence, non-maleficence, and justice. In wealthy countries, adequate resources exist to fund appropriate treatment; hence it should be provided to all based on distributive justice. In resource-limited countries, however, decisions regarding provision of care for expensive or complex health problems must be made with consideration for broader effects on the general public. Preliminary data from cost-effectiveness analysis indicate that many surgical interventions, including cardiac surgery, may be resource-efficient. Given that information, utilitarian ethical analysis supports dedication of resources to congenital heart surgery in many low-income countries. In the poorest countries, where access to drinking water and basic nutrition is problematic, it will often be more appropriate to focus on these issues first. CONCLUSION: Ethical analysis supports dedication of resources to congenital heart surgery in all but the poorest countries.

Teamwork and program organization in developing countries.

Establishment of congenital heart surgery programs in developing countries is often impeded by competition among providers for scarce resources and opportunities. To avoid this problem, the authors have sought to focus program development on a domestic medical team that includes a visiting North American surgeon. A leadership group was formed consisting of a domestic cardiologist and surgeon, the visiting surgeon, and leading local benefactors. Surgery was initiated beginning with closed cases, and the volume and complexity were gradually increased. The team was mentored by the visiting surgeon, and full medical brigades visited periodically. All members of the leadership group interacted with local health care providers, missionary groups, and visiting medical teams from international organizations, aiming to develop a single congenital heart surgery center. Over a period of 3 years, 185 children have been operated on and the team has progressed to do more complex open and closed cases. Overall mortality is 6.5%. Actively working with the program are 3 of the 5 local pediatric cardiologists, 2 of 4 pediatric intensivists, the only pediatric perfusionist, and the only active pediatric heart surgeon. Three additional international organizations currently participate in program development. Fundraising by the domestic nonprofit organization has increased approximately 20-fold in 5 years, and the program has been evaluated and approved by the government-based health insurance program. Focusing program development around a domestic leadership team allows coordination of patient referrals and resources, which contributes to excellent patient care and program sustainability.